In a multicenter trial in Spain, 7447 participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment (age range, 55 to 80 years, 57% were women), were randomly assigned to one of three diets:

Participants received quarterly educational sessions and, and depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts.

The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.

The two Mediterranean-diet groups had good adherence to the intervention. A primary end-point event occurred in 288 participants.

The multivariable-adjusted hazard ratios were 0.70 and 0.72 for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events).

Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events (the study was funded by the Spanish government).

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